{"id":10382,"date":"2026-06-30T10:48:41","date_gmt":"2026-06-30T02:48:41","guid":{"rendered":"https:\/\/regask.com\/?p=10382"},"modified":"2026-06-30T10:48:41","modified_gmt":"2026-06-30T02:48:41","slug":"surveillance-des-dispositifs-medicaux-juin-2026","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/medical-device-oversight-june-2026\/","title":{"rendered":"EUDAMED devient obligatoire\u00a0: la conformit\u00e9 des dispositifs m\u00e9dicaux se durcit\u2026"},"content":{"rendered":"<p id=\"ember1956\" class=\"ember-view reader-text-block__paragraph\"><span class=\"TextRun SCXW231934779 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW231934779 BCX0\"><strong>Au milieu de l&#039;ann\u00e9e 2026, la r\u00e9glementation relative aux dispositifs m\u00e9dicaux s&#039;est durcie simultan\u00e9ment sur trois des plus grands march\u00e9s mondiaux, faisant des dispositifs et des DIV le secteur le plus actif de la r\u00e9glementation des sciences de la vie que nous avons suivi.<\/strong> L&#039;UE a rendu obligatoire l&#039;utilisation de sa base de donn\u00e9es sur les dispositifs m\u00e9dicaux, la FDA am\u00e9ricaine a renforc\u00e9 les contr\u00f4les de qualit\u00e9 et la Chine a continu\u00e9 d&#039;ajuster son syst\u00e8me d&#039;enregistrement. Prises individuellement, aucune de ces mesures n&#039;est r\u00e9volutionnaire, mais ensemble, elles rehaussent les exigences minimales pour le maintien des produits sur le march\u00e9.<\/span><span class=\"NormalTextRun SCXW231934779 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW231934779 BCX0\">et les obligations convergent vers les donn\u00e9es, les syst\u00e8mes de qualit\u00e9 et la discipline d&#039;enregistrement.<\/span><\/span><span class=\"EOP Selected SCXW231934779 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-652431169\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-652431169 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3><strong><span class=\"TextRun MacChromeBold SCXW61593356 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW61593356 BCX0\">EUDAMED est devenu obligatoire dans toute l&#039;UE<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1116526527\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1116526527 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW224198092 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW224198092 BCX0\">La Commission europ\u00e9enne a rendu obligatoire l&#039;utilisation des quatre premiers modules EUDAMED, et les agences nationales\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">(<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">L&#039;Agence estonienne des m\u00e9dicaments en fait partie.<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">Il a \u00e9t\u00e9 confirm\u00e9 que la base de donn\u00e9es est d\u00e9sormais obligatoire en pratique. EUDAMED \u00e9tait attendue depuis des ann\u00e9es, ce qui a engendr\u00e9 un certain rel\u00e2chement\u00a0; le passage \u00e0 l\u2019obligation marque le moment o\u00f9 ce rel\u00e2chement se transforme en handicap. Les fabricants et les importateurs doivent s\u2019enregistrer, identifier leurs dispositifs et soumettre les documents requis, car des donn\u00e9es EUDAMED incompl\u00e8tes constituent de plus en plus un probl\u00e8me d\u2019acc\u00e8s au march\u00e9 plut\u00f4t qu\u2019un simple probl\u00e8me administratif. Ce travail est ingrat, mais il est d\u00e9sormais indispensable.<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">et le combler a posteriori sous la pression du temps est bien plus difficile que de le construire d\u00e8s le d\u00e9part.<\/span><\/span><span class=\"EOP SCXW224198092 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW166143349 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW166143349 BCX0\">Une lettre d&#039;avertissement de la FDA ciblait les syst\u00e8mes de contr\u00f4le qualit\u00e9 des dispositifs.<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1547690481\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1547690481 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW143045283 BCX0\">La FDA a adress\u00e9 une lettre d&#039;avertissement \u00e0 ZOLL Medical concernant des carences dans son syst\u00e8me de qualit\u00e9 et ses obligations de d\u00e9claration relatives aux dispositifs m\u00e9dicaux. Ce type de lettre d&#039;avertissement rappelle l&#039;importance des obligations post-commercialisation.\u00a0<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">(<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">Gestion des r\u00e9clamations, actions correctives et pr\u00e9ventives, signalement des \u00e9v\u00e9nements ind\u00e9sirables<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">Les exigences sont activement contr\u00f4l\u00e9es et ne se limitent pas \u00e0 la validation des crit\u00e8res d&#039;approbation. Une lacune du syst\u00e8me qualit\u00e9, m\u00eame minime dans la documentation interne, devient rapidement un document public faisant l&#039;objet d&#039;une enqu\u00eate, attirant l&#039;attention des clients, des partenaires et des autres organismes de r\u00e9glementation qui consultent les m\u00eames courriers. Rem\u00e9dier \u00e0 une lettre d&#039;avertissement est plus long et plus co\u00fbteux que de mettre en place un syst\u00e8me performant d\u00e8s le d\u00e9part.<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW59049111 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW59049111 BCX0\">La Chine a continu\u00e9 \u00e0 mettre \u00e0 jour l&#039;enregistrement et la classification des appareils.<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-289982262\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-289982262 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW215322073 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW215322073 BCX0\">L\u2019agence chinoise NMPA a mis \u00e0 jour les exigences d\u2019enregistrement et de d\u00e9p\u00f4t des dispositifs m\u00e9dicaux suite \u00e0 des ajustements de classification, tandis que le CMDE a men\u00e9 des consultations sur plusieurs projets de lignes directrices techniques. Le cadre r\u00e9glementaire chinois relatif aux dispositifs m\u00e9dicaux est en constante \u00e9volution, et les changements de classification sont trompeusement perturbateurs\u00a0: un dispositif reclass\u00e9 peut \u00eatre soumis \u00e0 des exigences diff\u00e9rentes en mati\u00e8re de preuves, de proc\u00e9dure de d\u00e9p\u00f4t ou de d\u00e9lais, parfois en cours de d\u00e9veloppement.<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW215322073 BCX0\">programme<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\">. Les fabricants vendant en Chine devraient\u00a0<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\">moniteur<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\"> La classification et les directives \u00e9voluent constamment et consid\u00e8rent l&#039;enregistrement comme une relation continue avec un cadre \u00e9volutif, et non comme un \u00e9v\u00e9nement ponctuel.<\/span><\/span><\/p>\n<h3><strong><span class=\"NormalTextRun SCXW56844195 BCX0\">Quoi\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">fait ceci<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">signifier<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u00a0pour\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">fabricants ?<\/span><\/strong><\/h3>\n\t<div id=\"gap-411171007\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-411171007 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW103495034 BCX0\">L&#039;UE, les \u00c9tats-Unis et la Chine actionnent diff\u00e9rents leviers.\u00a0<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">(<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">exhaustivit\u00e9 des bases de donn\u00e9es, contr\u00f4le de la qualit\u00e9 apr\u00e8s commercialisation et exigences d&#039;enregistrement<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">Mais l&#039;effet combin\u00e9 est une base de r\u00e9f\u00e9rence plus \u00e9lev\u00e9e et n\u00e9cessitant davantage de donn\u00e9es. Il convient de consid\u00e9rer l&#039;inscription \u00e0 EUDAMED, la pr\u00e9paration du syst\u00e8me qualit\u00e9 et le statut de classification chinois comme des obligations permanentes, march\u00e9 par march\u00e9, plut\u00f4t que comme des \u00e9tapes franchies une seule fois au lancement. En mati\u00e8re de r\u00e9glementation des dispositifs m\u00e9dicaux, les mauvaises surprises peuvent \u00eatre co\u00fbteuses.\u00a0<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">presque toujours<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">\u00a0provenir de quelque chose qui \u00e9tait conforme lors de son approbation et qui a discr\u00e8tement cess\u00e9 de l&#039;\u00eatre.\u00a0<\/span><a href=\"http:\/\/regask.com\/fr\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW103495034 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW103495034 BCX0\">\u00a0Ce service assure le suivi de la r\u00e9glementation des dispositifs m\u00e9dicaux et des DIV sur plus de 160 march\u00e9s, permettant ainsi aux fabricants d&#039;anticiper les changements de classification, de bases de donn\u00e9es et de r\u00e9glementation et d&#039;agir en cons\u00e9quence.<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Au milieu de l&#039;ann\u00e9e 2026, la conformit\u00e9 des dispositifs m\u00e9dicaux s&#039;est durcie simultan\u00e9ment sur trois des plus grands march\u00e9s mondiaux, faisant des dispositifs et des DIV le secteur le plus actif de la r\u00e9glementation des sciences de la vie que nous avons suivi. L&#039;UE a rendu obligatoire l&#039;utilisation de sa base de donn\u00e9es de dispositifs, la FDA am\u00e9ricaine a renforc\u00e9 ses contr\u00f4les sur la qualit\u00e9 des dispositifs et la Chine a continu\u00e9 d&#039;ajuster son syst\u00e8me d&#039;enregistrement. Aucun de ces changements n&#039;est spectaculaire pris isol\u00e9ment\u2026<\/p>","protected":false},"author":46,"featured_media":10383,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10382","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Medical Device Compliance 2026: Key Changes Ahead<\/title>\n<meta name=\"description\" content=\"Stay informed on medical device compliance 2026 as regulations tighten in major markets and EUDAMED becomes mandatory.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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